Management of stimulation safety limits in a neurostimulation system

ABSTRACT

An electrical stimulation system for use with a plurality of electrodes implanted within a tissue region comprises a neurostimulator configured for delivering electrical stimulation energy to the plurality of electrodes in accordance with a set of stimulation parameters, thereby injecting a charge into the tissue region, a control device configured for receiving user input to modify the set of stimulation parameters, and controller/processor circuitry configured for, in response to the user input computing a charge injection metric value as a function of a physical electrode parameter and an electrical source parameter for a first set of the electrodes, wherein the electrode set comprises at least two electrodes, comparing the computed charge injection metric value to a safety threshold value, and performing a corrective action based on the comparison.

RELATED APPLICATION DATA

The present application claims the benefit under 35 U.S.C. §119 to U.S.provisional patent application Ser. No. 61/808,224, filed Apr. 4, 2013.The foregoing application is hereby incorporated by reference into thepresent application in its entirety.

FIELD OF THE INVENTION

The present invention relates to management of stimulation safetylimits, and more particularly, to management of tissue safety limits ina neurostimulation system having more than one electrode.

BACKGROUND OF THE INVENTION

Implantable neurostimulation systems have proven therapeutic in a widevariety of diseases and disorders. Pacemakers and Implantable CardiacDefibrillators (ICDs) have proven highly effective in the treatment of anumber of cardiac conditions (e.g., arrhythmias). Spinal CordStimulation (SCS) systems have long been accepted as a therapeuticmodality for the treatment of chronic pain syndromes, and theapplication of tissue stimulation has begun to expand to additionalapplications, such as angina pectoris and incontinence. Further, inrecent investigations, Peripheral Nerve Stimulation (PNS) systems havedemonstrated efficacy in the treatment of chronic pain syndromes andincontinence, and a number of additional applications are currentlyunder investigation. More pertinent to the present inventions describedherein, Deep Brain Stimulation (DBS) has been applied therapeuticallyfor well over a decade for the treatment of neurological disorders,including Parkinson's Disease, essential tremor, dystonia, and epilepsy,to name but a few. Further details discussing the treatment of diseasesusing DBS are disclosed in U.S. Pat. Nos. 6,845,267, 6,845,267, and6,950,707, which are expressly incorporated herein by reference.

Each of these implantable neurostimulation systems typically includesone or more electrode carrying stimulation leads, which are implanted atthe desired stimulation site, and a neurostimulator implanted remotelyfrom the stimulation site, but coupled either directly to theneurostimulation lead(s) or indirectly to the neurostimulation lead(s)via a lead extension. A single stimulation lead may contain electrodesof different sizes. The neurostimulation system may further comprise ahandheld external control device to remotely instruct theneurostimulator to generate electrical stimulation pulses in accordancewith selected electrical stimulation parameters.

Electrical stimulation energy may be delivered from the neurostimulatorto the electrodes in the form of an electrical pulsed waveform. Thus,the stimulation energy may be controllably delivered to the electrodesto stimulate the tissue. The set of electrodes, including those on andoff the lead, used to deliver the electrical pulses to the targetedtissue constitutes an electrode set, with the electrodes capable ofbeing selectively programmed to act as anodes (positive), cathodes(negative), and/or left off (zero). In other words, an electrode setrepresents the polarity being positive, negative, or zero. Otherparameters that may be controlled or varied include, but are not limitedto, the amplitude, width, rate, regularity, and ramp of the electricalpulses provided through the electrode array. Each electrode set, alongwith its electrical pulse parameters, can be referred to as a“stimulation parameter set.”

With some neurostimulation systems, and in particular, those withindependently controlled current and/or voltage sources, thedistribution of the current to the electrodes (including the case of theneurostimulator, which may act as an electrode) may be varied such thatthe current is supplied via numerous different electrode configurations.In different configurations, the electrodes may provide current orvoltage in different relative percentages of positive and negativecurrent or voltage to create different electrical current distributions(i.e. fractionalized electrode sets).

As briefly discussed above, an external control device can be used toinstruct the neurostimulator to generate electrical stimulation pulsesin accordance with selected stimulation parameters. Typically, thestimulation parameters programmed into the neurostimulator can beadjusted by the user by manipulating controls on the external usercontrol device to modify the electrical stimulation provided by theneurostimulator system to the patient. Thus, in accordance with thestimulation parameters programmed by the external control device,electrical pulses can be delivered from the neurostimulator to thestimulation electrode(s) to stimulate, activate, or affect a volume oftissue in accordance with the set of stimulation parameters and providethe desired efficacious therapy to the patient. The best stimulusparameter set will typically be one that delivers stimulation energy tothe volume of tissue that must be stimulated in order to provide thetherapeutic benefit (e.g., treatment of pain), while minimizing theamount of non-target tissue that is stimulated. A typical stimulationparameter set may include the electrodes that acting as anodes orcathodes, as well as the amplitude, duration, and rate of thestimulation pulses.

To facilitate the selection of the stimulation parameters, the cliniciangenerally programs the external control device, and if applicable theneurostimulator, through a computerized programming system. Thisprogramming system can be a self-contained hardware/software system, orcan be defined predominately by software that is run on a standardpersonal computer (PC). The PC or custom hardware may actively controlthe characteristics of the electrical stimulation generated by theneurostimulator to allow the optimum stimulation parameters to bedetermined based on patient feedback, or other means, and tosubsequently program the external control device with the optimumelectrical stimulation parameters.

When electrical leads are implanted within the patient, the computerizedprogramming system may be used to instruct the neurostimulator to applyelectrical stimulation to test placement of the leads and/or electrodes,thereby assuring that the leads and/or electrodes are implanted ineffective locations within the patient. Once the leads are correctlypositioned, a fitting procedure, which may be referred to as anavigation session, may be performed using the computerized programmingsystem to program the external control device, and if applicable theneurostimulator, with a set of stimulation parameters that bestaddresses the disorder or painful site.

Significantly, there are limits to how much charge (both in terms oftotal charge per pulse (or phase) and charge density per pulse) can beinjected into tissue using one manner (e.g. biphasic, charge-balancedwaveforms) without causing cell trauma and/or electrochemical damage(i.e., corrosion) to the electrodes. Each electrode, depending upon itsphysical properties (which include, but are not limited to, its size,shape, material, surface characteristics, and/or state), has a chargethreshold level (which may also be affected by implant location,adjacent tissue type, and other biological factors) that should not beexceeded to ensure that the amount of charge applied to the electrodewill not cause irreparable electrochemical harm to the electrode orinduce cellular trauma. Smaller sized electrodes generally have lowercharge threshold levels than larger sized electrodes that aremanufactured of the same material because the smaller sized electrodeshave higher charge densities.

Thus, with regard to tissue safety, both total charge and charge densityhave been taken into account to avoid cell trauma. As such, the Shannonmodel, which accounts for a single electrode of a surface area “A”through which a charge amount “Q” is injected, was created in 1992 forevaluating tissue safety limits. In particular, the Shannon modelcalculates a k-value in accordance with the equation:

$\begin{matrix}{k = {{{\log_{10}\left( \frac{Q}{A} \right)} + {\log_{10}(Q)}} = {{\log_{10}\left( \frac{Q^{2}}{A} \right)}.}}} & \lbrack 1\rbrack\end{matrix}$

(See Shannon, R. V., A Model of Safe Levels for Electrical Stimulation,IEEE-TBME, Vol. 39, No. 4, pp. 424-426, April 1992). It should beappreciated that the value of k comprises two terms: the log of thecharge density, and the log of the charge. The author proposed that atissue safety limit of k equal to 1.5 or lower should be maintained toensure tissue safety given the assumptions listed in the publication.

Management of charge injection for safe stimulation in commercialstimulators today is performed using one variable (charge density) on anelectrode-by-electrode basis. This approach is sufficient forpresent-day stimulation systems and electrode surface areas, becauseside-effects prohibit a clinician from practically reaching a tissuesafety limit. In particular, a patient undergoing neurostimulationtherapy would be expected to exhibit side effects well before celltrauma would occur. The onset of side-effects is primarily caused by thetotal charge per pulse, thereby naturally limiting the total charge perpulse (as well as the charge density per pulse) that can be applied tothe patient. Due to the relatively large area, and resulting low chargedensity, of prior art electrodes, the charge density per pulse is alsonaturally limited by the side-effects experienced by the patient.

While managing charge injection for safe stimulation based on the chargedensity for each electrode may be acceptable for conventionalneurostimulation systems, such charge injection management does notadhere to the Shannon model. For example, if electrical current at 450μs and 4 mA is delivered to a single active electrode having a surfacearea of 0.06 cm², the charge, charge density, and k-value are 1.8 μs, 30μC/cm², and 1.73, respectively. If the amplitude of the electricalcurrent is doubled to 8 mA, and the surface area of the electrode isdoubled to 0.12 cm², the charge-density remains the same (30 μC/cm²),but the k-value increases substantially to 2.03. This example shows thata charge-density limit alone does not manage the k-value, and can resultin breaches of a k-value threshold designed for one electrode.

Although conformance with the Shannon model may not be necessary when anelectrode is relatively large, as the size of electrodes becomes smaller(e.g., the use of segmented electrodes is becoming prevalent in thecontext of DBS), thereby effectively increasing the charge density perpulse, it may be possible to cause cell trauma before the onset ofside-effects. Therefore, an improved charge management solution isneeded as new leads are developed with smaller electrodes andside-effects cannot be relied on to naturally manage adherence to theShannon model.

It is possible that for a case of multiple active electrodes, anapproach that relies on the Shannon model (or a surrogate parameter fork, such as charge-density or charge as a function of surface area), butwhich replaces the electrode surface area with a cumulative or effectivecontact surface area (e.g., could be a sum of active electrode surfaceareas or the sum of active electrode surface areas multiplied by adispersion factor greater than 1 to get credit for the expanded spatialdistribution) could be used. Such an approach, which is in essence areduction of the problem to the Shannon model, seems reasonable for thecase where a single electrical source is used and all active electrodes(of the same polarity) are at the same potential. However, use ofindependent electrical sources (e.g., like multiple independent currentcontrol (MICC) devices) can create distributions of currents that arenot readily reduced to the Shannon model, and a new approach is needed.

SUMMARY OF THE INVENTION

In accordance with the present invention, a neurostimulation system foruse with a plurality of electrodes implanted within a tissue region isprovided. The neurostimulation system comprises a neurostimulator (whichmay be implantable) configured for delivering electrical stimulationenergy to the plurality of electrodes in accordance with a set ofstimulation parameters, thereby injecting a charge into the tissueregion. The neurostimulation device further comprises a control deviceconfigured for receiving user input to modify the stimulation parameterset, and controller/processor circuitry, which may be, e.g., containedin the control device, the neurostimulator, or both. The control devicemay be an external control device, or alternatively, an internal controldevice separate from the IPG.

The controller/processor circuitry is configured for, in response to theuser input, computing a charge injection metric value as a function of aphysical electrode parameter (e.g., at least one of an electrode surfacearea, an electrode surface shape, and an electrode material) and anelectrical source parameter (e.g., at least one of a current, a voltage,a charge, charge density, and an impedance) for a set of the electrodes,wherein the electrode set comprises at least two electrodes, comparingthe computed charge injection metric value to a safety threshold value,and performing a corrective action based on the comparison.

The corrective action may, e.g., comprise preventing theneurostimulation device from delivering the electrical stimulationenergy to the plurality of electrodes. Or the corrective action may,e.g., comprise delivering the electrical stimulation energy to theelectrode set in accordance with a different set of stimulationparameters. Or the corrective action may, e.g., comprise directing thecontrol device to convey an warning signal to the user.

In one embodiment, the controller/processor circuitry is configured fordirecting the neurostimulator to deliver the electrical stimulationenergy to the plurality of electrodes in accordance with the modifiedstimulation parameter set if the computed charge injection metric valuedoes not breach the threshold charge injection metric value, andperforming the corrective action if the computed charge injection metricvalue breaches the threshold charge injection metric value.

If the physical electrode parameter is an electrode surface area, andthe electrical source parameter is a charge, the ratios between theinjected charge and the surface area for at least two of the electrodesmay be different. The tissue charge injection safety value may becomputed in accordance with the equation

${{k\; 2} = \left( {\log_{10}{\sum\limits_{i = 1}^{n}\frac{Q_{i}^{2}}{A_{i}}}} \right)},$

where k2 is the tissue charge injection safety value, i is an electrodedesignator, n is the number of electrodes, Q_(i) is the charge injectedby the electrode i, and A_(i) is the surface area of the electrode i. Orthe tissue charge injection safety value may be computed in accordancewith the equation

${{k\; 2} = \left( {\log_{10}{\sum\limits_{i = 1}^{n}{W_{i}\frac{Q_{i}^{2}}{A_{i}}}}} \right)},$

where k2 is the tissue charge injection safety value, i is an electrodedesignator, n is the number of electrodes, Q_(i) is the charge injectedby the electrode i, A_(i) is the surface area of the electrode i, and Wiis a weighting value for the electrode i. The weighting value W_(i) maybe, e.g., a binary value or a graduated value. In one embodiment, thecontroller/processor circuitry is configured for determining theweighting value W_(i) for each electrode in the electrode set based onan adjacency of the respective electrode relative to a referenceelectrode in the electrode set. In another embodiment, thecontroller/processor circuitry is configured for determining theweighting value W_(i) for each electrode in the electrode set based on apolarity of the respective electrode. In another embodiment, W_(i) maydepend on another system parameter, e.g. rate, or maximum instantaneousrate.

The neurostimulation system may further comprise memory storing aplurality of different safety threshold values, in which case, thecontroller/processor circuitry may be configured for selecting thesafety threshold value from the different safety threshold values basedon a characteristic (e.g., the same frequency or the same polarity)shared by the electrode set

In an optional embodiment, multiple k2-values may be computed fordifferent sets of electrodes. In this case, the controller/processorcircuitry may be configured for, in response to the user input,computing at least one other charge injection metric value as a functionof a physical electrode parameter and an electrical source parameter foreach of at least one other set of the electrodes. Each of the set ofelectrodes and the other electrode(s) are different from each other, andeach of the other electrode set(s) comprises at least two electrodes.The controller/processor circuitry may be further configured forcomparing a function (e.g., a maximum, a sum, an average, or a minimum)of the computed charge injection metric value and the at least one othercomputed charge injection metric value to the safety threshold value,and performing the corrective action based on the computed function.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is block diagram of a deep brain stimulation (DBS) systemarranged in accordance with the present inventions;

FIG. 2 is a plan view of an implantable pulse generator (IPG) and twopercutaneous neurostimulation leads used in the DBS system of FIG. 1;

FIG. 3 is a plan view of the DBS system of FIG. 1 in use with a patient;

FIG. 4 is a block diagram of the internal components of a clinician'sprogrammer (CP) used in the DBS system of FIG. 1;

FIG. 5 a is a table illustrating k2-values and original k-valuescomputed for different electrical current distributions between twoelectrodes of the same size;

FIG. 5 b is a diagram of the computed k2-values and original k-values ofthe table in FIG. 5 a;

FIG. 6 a is a table illustrating k2-values and original k-valuescomputed for different electrical current distributions between twoelectrodes of different sizes;

FIG. 6 b is a diagram of the computed k2-values and original k-values ofthe table in FIG. 6 a;

FIG. 7 a is a table illustrating k2-values and original k-valuescomputed for different electrical current distributions between threeelectrodes of the same size;

FIG. 7 b is a diagram of the computed k2-values and original k-values ofthe table in FIG. 7 a;

FIG. 8 a is a table illustrating k2-values and original k-valuescomputed for different electrical current distributions between threeelectrodes of different sizes;

FIG. 8 b is a diagram of the computed k2-values and original k-values ofthe table in FIG. 8 a;

FIG. 9 a is a table illustrating weighting values for the electrodesused to compute a k2-value; and

FIG. 9 b is a table illustrating weighting values for the electrodesused to compute another k2-value.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The description that follows relates to a deep brain stimulation (DBS)system. However, it is to be understood that the while the inventionlends itself well to applications in DBS, the invention, in its broadestaspects, may not be so limited. Rather, the invention may be used withany type of implantable electrical circuitry used to stimulate tissue.For example, the present invention may be used as part of a pacemaker, adefibrillator, a cochlear stimulator, a retinal stimulator, a stimulatorconfigured to produce coordinated limb movement, a cortical stimulator,a spinal cord stimulator, peripheral nerve stimulator, microstimulator,or in any other neural stimulator configured to treat urinaryincontinence, sleep apnea, shoulder sublaxation, headache, etc.

Turning first to FIG. 1, an exemplary DBS neurostimulation system 10generally includes at least one implantable stimulation lead 12 (in thiscase, two), a neurostimulator in the form of an implantable pulsegenerator (IPG) 14, an external remote controller RC 16, a clinician'sprogrammer (CP) 18, an External Trial Stimulator (electrodes ETS) 20,and an external charger 22.

The IPG 14 is physically connected via one or more percutaneous orsubdural lead extensions 24 to the neurostimulation leads 12, whichcarry a plurality of electrodes 26 arranged in an array. In theillustrated embodiment, the neurostimulation leads 12 are percutaneousleads, and to this end, the electrodes 26 may be arranged in-line alongthe neurostimulation leads 12. In alternative embodiments, theelectrodes 26 may be arranged in a two-dimensional pattern on a singlepaddle lead if cortical brain stimulation is desired, or in a non-linearfashion about the lead, as in e.g. directional leads. As will bedescribed in further detail below, the IPG 14 includes pulse generationcircuitry that delivers electrical stimulation energy in the form of apulsed electrical waveform (i.e., a temporal series of electricalpulses) to the electrode array 26 in accordance with a set ofstimulation parameters.

The ETS 20 may also be physically connected via the percutaneous orsubdural lead extensions 28 and external cable 30 to theneurostimulation leads 12. The ETS 20, which has similar pulsegeneration circuitry as the IPG 14, also delivers electrical stimulationenergy in the form of a pulse electrical waveform to the electrode array26 accordance with a set of stimulation parameters. The major differencebetween the ETS 20 and the IPG 14 is that the ETS 20 is anon-implantable device that is used on a trial basis after theneurostimulation leads 12 have been implanted and prior to implantationof the IPG 14, to test the responsiveness of the stimulation that is tobe provided. Thus, any functions described herein with respect to theIPG 14 can likewise be performed with respect to the ETS 20.

The RC 16 may be used to telemetrically control the ETS 20 via abi-directional RF communications link 32. Once the IPG 14 andneurostimulation leads 12 are implanted, the RC 16 may be used totelemetrically control the IPG 14 via a bi-directional RF communicationslink 34. Such control allows the IPG 14 to be turned on or off and to beprogrammed with different stimulation parameter sets. The IPG 14 mayalso be operated to modify the programmed stimulation parameters toactively control the characteristics of the electrical stimulationenergy output by the IPG 14. As will be described in further detailbelow, the CP 18 provides clinician detailed stimulation parameters forprogramming the IPG 14 and ETS 20 in the operating room and in follow-upsessions.

The CP 18 may perform this function by indirectly communicating with theIPG 14 or ETS 20, through the RC 16, via an IR communications link 36.Alternatively, the CP 18 may directly communicate with the IPG 14 or ETS20 via an RF communications link (not shown). The clinician detailedstimulation parameters provided by the CP 18 are also used to programthe RC 16, so that the stimulation parameters can be subsequentlymodified by operation of the RC 16 in a stand-alone mode (i.e., withoutthe assistance of the CP 18).

The external charger 22 is a portable device used to transcutaneouslycharge the IPG 14 via an inductive link 38. Once the IPG 14 has beenprogrammed, and its power source has been charged by the externalcharger 22 or otherwise replenished, the IPG 14 may function asprogrammed without the RC 16 or CP 18 being present. For purposes ofbrevity, the details of the external charger 22 will not be describedherein.

For the purposes of brevity, the details of the RC 16, ETS 20, andexternal charger 22 are described in U.S. Pat. No. 6,895,280, which isexpressly incorporated herein by reference.

Referring to FIG. 2, the IPG 14 comprises an outer case 40 for housingthe electronic and other components (described in further detail below),and a connector 42 to which the proximal end of the neurostimulationlead 12 mates in a manner that electrically couples the electrodes 26 tothe internal electronics (described in further detail below) within theouter case 40. The outer case 40 is composed of an electricallyconductive, biocompatible material, such as titanium, and forms ahermetically sealed compartment wherein the internal electronics areprotected from the body tissue and fluids. In some cases, the outer case40 may serve as an electrode.

Each of the neurostimulation leads 12 comprises an elongated cylindricallead body 43, and the electrodes 26 take the form of ring electrodesmounted around the lead body 43. One of the neurostimulation leads 12has eight electrodes 26 (labeled E1-E8), and the other stimulation lead12 has eight electrodes 26 (labeled E9-E16). The actual number and shapeof leads and electrodes will, of course, vary according to the intendedapplication. Further details describing the construction and method ofmanufacturing percutaneous stimulation leads are disclosed in U.S.patent application Ser. No. 11/689,918, entitled “Lead Assembly andMethod of Making Same,” and U.S. patent application Ser. No. 11/565,547,entitled “Cylindrical Multi-Contact Electrode Lead for NeuralStimulation and Method of Making Same,” the disclosures of which areexpressly incorporated herein by reference.

The IPG 14 includes a battery and pulse generation circuitry (not shown)that delivers the electrical stimulation energy in the form of a pulsedelectrical waveform to the electrode array 26 in accordance with a setof stimulation parameters programmed into the IPG 14. Such stimulationparameters may comprise electrode sets, which define the electrodes thatare activated as anodes (positive), cathodes (negative), and turned off(zero), percentage of stimulation energy assigned to each electrode(fractionalized electrode configurations), and electrical pulseparameters, which define the pulse amplitude (measured in milliamps orvolts depending on whether the IPG 14 supplies constant current orconstant voltage to the electrode array 26), pulse duration (measured inmicroseconds), pulse rate (measured in pulses per second), and burstrate (measured as the stimulation on duration X and stimulation offduration Y). The IPG 14 may be capable of delivering the stimulationenergy to the electrode array 26 over multiple channels or over only asingle channel.

Electrical stimulation will occur between two (or more) activatedelectrodes, one of which may be the IPG case. Simulation energy may betransmitted to the tissue in a monopolar or multipolar (e.g., bipolar,tripolar, etc.) fashion. Monopolar stimulation occurs when a selectedone of the lead electrodes 26 is activated along with the case of theIPG 14, so that stimulation energy is transmitted between the selectedelectrode 26 and case. Bipolar stimulation occurs when two of the leadelectrodes 26 are activated as anode and cathode, so that stimulationenergy is transmitted between the selected electrodes 26. Tripolarstimulation occurs when three of the lead electrodes 26 are activated,two as anodes and the remaining one as a cathode, or two as cathodes andthe remaining one as an anode.

In the illustrated embodiment, the IPG 14 can individually control themagnitude of electrical current flowing through each of the electrodes.In this case, it is preferred to have a current generator, whereinindividual current-regulated amplitudes from independent current sourcesfor each electrode may be selectively generated. Although this system isoptimal to take advantage of the invention, other stimulators that maybe used with the invention include stimulators having voltage regulatedoutputs. While individually programmable electrode amplitudes areoptimal to achieve fine control, a single output source switched acrosselectrodes may also be used, although with less fine control inprogramming. Mixed current and voltage regulated devices may also beused with the invention.

The IPG 14 includes a Coulomb counter (not shown) that measures thedelivery of charge to the tissue region by the electrodes 26 inCoulombs. The Coulomb counter is used to measure or calculate thequantity of charge flowing into the tissue region to thereby providerates of the charging of the tissue. In particular, the Coulomb countermay determine the amount of tissue charge at the electrodes 26 bymeasuring a voltage drop across a low impedance series resistance on theneurostimulation lead(s) 12.

Alternatively, rather than monitoring the amount of tissue charge, theIPG 14 or the CP 18 may be able to generate an estimate of an amount oftissue charge at each of the electrodes 26 based on the stimulationparameters that are programmed for the electrodes 26. In particular, theamount of charge actually delivered in a stimulation pulse is related tothe characteristics of the stimulation pulse.

When the pulse amplitude characterizes the current amplitude of thestimulation pulses in the stimulus waveform, the amount of chargeactually delivered can be estimated in accordance with the followingequation:

Q≈(PA)(PD),  [2]

where Q is the delivered charge, PA is the pulse amplitude, and PD isthe pulse duration. Equation [1] can be adjusted to accommodate variousforms of pulse amplitude. For example, when the pulse amplitude changesover time, Equation [1] can be changed to a time integral that includesthe changing pulse amplitude.

Conversely, when the pulse amplitude characterizes the voltage amplitudeof the stimulation pulses in the stimulus waveform, the amount of chargeactually delivered (Q) can be estimated in accordance with the followingequation:

Q≈(PA)(PD)/z,  [3]

where Q is the delivered charge, PA is the pulse amplitude, PD is thepulse duration, and Z is the electrical impedance of current flow fromone electrode 26 through the tissue to another electrode 26. Electricalimpedance can vary over time with changes in the electrodes 26 and/orsurrounding tissue. For example, the location of an electrode 26 withina moving body can vary over time, the electrical characteristics oftissue at the site of stimulation can vary over time, the electrode 26itself can become contaminated (e.g., biofouling) or otherwise changeover time, or the electrode-electrolyte interface can vary over time.

The impedance Z can be determined repeatedly during the operation of theneurostimulation system 10. Alternatively, the impedance Z can beestimated and programmed into the system 10. Equation [2] can beadjusted to accommodate various forms of pulse amplitude and impedanceZ. For example, when the pulse amplitude and/or impedance Z changes overtime, Equation [2] can be changed to a time integral that includes thechanging pulse amplitude and/or impedance Z. Further details discussingthe estimating of the tissue charge at each of the electrodes 26 aredisclosed in U.S. Pat. No. 7,801,600, which is expressly incorporatedherein by reference. Further details discussing the detailed structureand function of IPGs are described more fully in U.S. Pat. Nos.6,516,227 and 6,993,384, which are expressly incorporated herein byreference.

As shown in FIG. 3, two percutaneous neurostimulation leads 12 areintroduced through a burr hole 46 (or alternatively, two respective burrholes) formed in the cranium 48 of a patient 44, and introduced into theparenchyma of the brain 49 of the patient 44 in a conventional manner,such that the electrodes 26 are adjacent a target tissue region, thestimulation of which will treat the dysfunction (e.g., the ventrolateralthalamus, internal segment of globus pallidus, substantia nigra parsreticulate, subthalamic nucleus, or external segment of globuspallidus). Thus, stimulation energy can be conveyed from the electrodes26 to the target tissue region to change the status of the dysfunction.Due to the lack of space near the location where the neurostimulationleads 12 exit the burr hole 46, the IPG 14 is generally implanted in asurgically-made pocket either in the chest, or in the abdomen. The IPG14 may, of course, also be implanted in other locations of the patient'sbody. The lead extension(s) 24 facilitates locating the IPG 14 away fromthe exit point of the neurostimulation leads 12.

As briefly discussed above, the CP 18 greatly simplifies the programmingof multiple electrode sets, allowing the physician or clinician toreadily determine the desired stimulation parameters to be programmedinto the IPG 14, as well as the RC 16. Thus, modification of thestimulation parameters in the programmable memory of the IPG 14 afterimplantation is performed by a clinician using the CP 18, which candirectly communicate with the IPG 14 or indirectly communicate with theIPG 14 via the RC 16. That is, the CP 18 can be used by the physician orclinician to modify operating parameters of the electrode array 26 inthe brain.

The overall appearance of the CP 18 is that of a laptop personalcomputer (PC), and in fact, may be implanted using a PC that has beenappropriately configured to include a directional-programming device andprogrammed to perform the functions described herein. Alternatively, theCP 18 may take the form of a mini-computer, personal digital assistant(PDA), etc., or even a remote control (RC) with expanded functionality.Thus, the programming methodologies can be performed by executingsoftware instructions contained within the CP 18. Alternatively, suchprogramming methodologies can be performed using firmware or hardware.In any event, the CP 18 may actively control the characteristics of theelectrical stimulation generated by the IPG 14 to allow the optimumstimulation parameters to be determined based on patient response andfeedback and for subsequently programming the IPG 14 with the optimumstimulation parameters.

Referring to FIG. 4, to allow the user to perform these functions, theCP 18 includes a standard user input device 72 (e.g., a keyboard, mouse,joystick, etc.) to allow a clinician to input information and controlthe process and a display monitor 76 housed in a case. In theillustrated embodiment, the monitor 76 is a conventional screen.Alternatively, instead of being conventional, the monitor 76 may be adigitizer screen, such as touchscreen (not shown), and may be used inconjunction with an active or passive digitizer stylus/finger touch. TheCP 18 generally includes a controller/processor 80 (e.g., a centralprocessor unit (CPU)) and memory 82 that stores a stimulationprogramming package 84, which can be executed by thecontroller/processor 80 to allow the user to program the IPG 14, and RC16. The CP 18 further includes output circuitry 86 (e.g., via thetelemetry circuitry of the RC 16) for downloading stimulation parametersto the IPG 14 and RC 16 and for uploading stimulation parameters alreadystored in the memory 66 of the RC 16, via the telemetry circuitry 68 ofthe RC 16. Notably, while the controller/processor 80 is shown in FIG. 4as a single device, the processing functions and controlling functionscan be performed by a separate controller and processor.

Execution of the programming package 84 by the controller/processor 80provides a multitude of display screens (not shown) that can benavigated through via the user input device 72. These display screensallow the clinician to, among other functions, to select or enterpatient profile information (e.g., name, birth date, patientidentification, physician, diagnosis, and address), enter procedureinformation (e.g., programming/follow-up, implant trial system, implantIPG, implant IPG and lead(s), replace IPG, replace IPG and leads,replace or revise leads, explant, etc.), generate a therapy-relevant mapof the patient, define the configuration and orientation of the leads,initiate and control the electrical stimulation energy output by theleads 12, and select and program the IPG 14 with stimulation parametersin both a surgical setting and a clinical setting. Further detailsdiscussing the above-described CP functions are disclosed in U.S. patentapplication Ser. No. 12/501,282, entitled “System and Method forConverting Tissue Stimulation Programs in a Format Usable by anElectrical Current Steering Navigator,” and U.S. patent application Ser.No. 12/614,942, entitled “System and Method for Determining AppropriateSteering Tables for Distributing Stimulation Energy Among MultipleNeurostimulation Electrodes,” which are expressly incorporated herein byreference.

As discussed in the background, there are limits as to how much charge(both in terms of total charge per pulse (or phase) and charge densityper pulse) can be injected into tissue without causing any tissue damageor can be applied to the electrodes without causing any electrochemicaldamage (i.e. corrosion) to the electrodes. To prevent any possibletissue damage or electrode damage from occurring, thecontroller/processor 80 is configured for computing a charge injectionmetric value in response to input from the user that modifies a set ofstimulation parameters (e.g., if the user attempts to increase theamplitude of the stimulation energy to the electrodes 26 or steerselectrical current between the electrodes 26), comparing the computedcharge injection metric value to a safety threshold value, andperforming a corrective action based on the comparison.

In the illustrated embodiment, the charge injection metric value iscomputed based on a monitored injection charge of the currentlydelivered electrical energy (e.g., using the Coulomb counter containedin the IPG 14). However, in certain embodiments, the tissue chargeinjection metric value can be computed by the CP 18 or the IPG 14 basedon a charge value estimated from a stimulation parameter or parametersselected by the user (e.g., using equations [1] or [2]), so that theelectrical energy need not be monitored.

The corrective action may, e.g., comprise preventing the IPG 14 fromdelivering the electrical stimulation energy to the electrodes 26. Forexample, the IPG 14 In this case, the threshold value may define a hardstop limit. Or the corrective action may, e.g., comprise delivering theelectrical stimulation energy to the electrodes 26 in accordance with adifferent set of stimulation parameters. The different set ofstimulation parameters may be the current set of stimulation parametersin accordance with which electrical stimulation energy was delivered tothe patient prior to the last user input. Or, the different set ofstimulation parameters may be computed using a heuristic set of rulesthat ensures that the charge injection metric value does not exceed thesafety threshold value.

In the case where the user input is steering current, e.g., inaccordance with current steering algorithms discussed in U.S. Pat. No.6,052,624, the different set of stimulation parameters may be adifferent fractionalized electrode combination. For example, theelectrical stimulation energy may be steered along the tissue region byfirst incrementally shifting electrical current from a first electrodeto a second electrode. When the charge injection metric value breachesthe safety threshold value, the electrical current may be incrementallyshifting from the first electrode to a third electrode. In the caseswhere electrical stimulation energy is prevented from being delivered tothe active electrodes 26 or electrical stimulation energy is deliveredto the active electrodes 26 in accordance with a different set ofstimulation parameters, the safety threshold value may take the form ofa hard stop limit.

Or the corrective action may be conveying a user-discernible warningsignal to the user (e.g., a binary signal, such as a visual signal, anaural signal, a vibratory signal, and a modulated neurostimulationsignal) or a user-discernible notification message to the user. In thiscase, the threshold value may define a warning threshold.

In the illustrated embodiment, the hard stop limits and/or warningthresholds are user-programmable to allow the user the flexibility ofmodifying them from the manufacturer set hard stop limits, which aretypically selected to be at the upper threshold of the tissue safetylimit and, as such, can sometimes be dangerously close for a physician'scomfort level. In alternative embodiments, the IPG 14 may automaticallydetect the type of neurostimulation leads coupled to it (and thus, thecharacteristics (e.g., size, shape, material, etc.) of the electrodescarried by the leads), which information could be used by either the IPG14 or the CP 18 to automatically modify the hard stop limits and/orwarning thresholds. In this manner, the user will not have to guess orotherwise take the time to determine what the values of the hard stoplimits and/or warning thresholds should be.

The hard stop limits and/or warning thresholds for the electrodes may beprogrammable by the user into the system 10 through means of a numericaltextual entry, up/down arrow push buttons, a touch screen interface,and/or a user audio interface located on the CP 18. In particular, theCP 18 includes a programming screen that enables the user to programtheir desired stimulation hard stop limit values and/or warningthreshold values into the neurostimulation system. This feature isuseful if the user would like to be warned of the occurrence of aspecific stimulation level when it is reached, or if the user would liketo program the electrode(s) to not meet or exceed a specific stimulationlevel. Further details discussing programmable hard stop limits and/orwarning thresholds are disclosed in U.S. patent application Ser. No.13/470,158, entitled “Management of Stimulation Safety Limits in aNeurostimulation System,” which is expressly incorporated herein byreference.

It can be appreciated that the manner in which the neurostimulationsystem 10 controls the tissue charge injection based on the hard stoplimit and/or the warning threshold will depend on where the tissuecharge injection is monitored or estimated and where the monitored orestimated tissue charge injection is compared to the hard stop limitand/or the warning threshold.

In the illustrated embodiment, the CP 18 both estimates the tissuecharge injection at the active electrodes 26 and performs the correctiveaction. In particular, the CP 18 computes an estimate of the tissuecharge injection the active electrodes 26 based on the programmedstimulation parameters, derives the charge injection metric value fromthe tissue charge injection data obtained or estimated by the IPG 14 orCP 18, and determines whether the derived charge injection metric valuebreaches the hard stop limit and/or the warning threshold. If the CP 18determines that the charge injection metric value breaches the hard stoplimit and/or warning threshold, the CP 18 performs the corrective actionor instructs the IPG 14 to perform the corrective action.

Alternatively, the IPG 14 both monitors or estimates the tissue chargeinjection at the active electrodes and performs any corrective action.In particular, the IPG 14 obtains the tissue charge injection data fromthe active electrodes 26 or computes an estimate of the tissue chargeinjection data based on the programmed stimulation parameters, derivesthe charge injection metric value from the obtained or estimated tissuecharge injection data, and determines whether the derived chargeinjection metric value breaches the hard stop limit and/or the warningthreshold. If the IPG 14 determines that the charge injection metricvalue breaches the hard stop limit and/or warning threshold, the IPG 14performs the corrective action or instructs the CP 18 to perform thecorrective action.

Alternatively, the IPG 14 monitors or estimates the tissue chargeinjection at the active electrodes 26, while the CP 18 performs thecorrective action if needed. In particular, the IPG 14 obtains thetissue charge injection data from the active electrodes 26 or computesan estimate of the tissue charge injection data based on the programmedstimulation parameters, and sends the tissue charge injection data tothe CP 18, which derives the charge injection metric value from theobtained or estimated tissue charge injection data, and determineswhether the derived injection metric value breaches the hard stop limitand/or the warning threshold. If the CP 18 determines that the chargeinjection metric value breaches the hard stop limit and/or the warningthreshold, the CP 18 performs the corrective action or instructs the IPG14 to perform the corrective action.

More alternatively, the CP 18 estimates the tissue charge injection atthe electrodes 26, and the IPG 14 performs the corrective action. Inparticular, the CP 18 computes an estimate of the tissue chargeinjection at the electrodes 26 based on the programmed stimulationparameters, and sends the tissue charge injection data to the IPG 14.The IPG 14 receives the estimated tissue charge injection data from theCP 18, derives the charge injection metric value from the estimatedtissue charge injection data, and determines whether the derived chargeinjection metric value has met or exceeded the hard stop limit and/orthe warning threshold. If the IPG 14 determines that the chargeinjection metric value breaches the hard stop limit and/or warningthreshold, the IPG 14 performs the corrective action or instructs the CP18 to perform the corrective action.

Significantly, much like the original k-value, the charge injectionmetric value is a function of a physical electrode parameter (e.g.,electrode surface area, electrode surface shape, or an electrodematerial) and an electrical source parameter (e.g., current, voltage,charge, charge density, and impedance). However, unlike the originalk-value, the charge injection metric value is computed for multipleelectrodes at one time, rather than being computed on anelectrode-by-electrode basis. In the embodiment illustrated herein, thecharge injection metric value considers the electrode surface area andcharge for distinct electrodes as independent contributors to a final“k” value, described as “k2” in the following equation:

$\begin{matrix}{{{k\; 2} = {\log_{10}\left( {\sum\limits_{i = 1}^{n}\frac{Q_{i}^{2}}{A_{i}}} \right)}},} & \lbrack 4\rbrack\end{matrix}$

where i is an electrode designator, n is the number of electrodes, Q_(i)is the charge injected by the electrode i, and A_(i) is the surface areaof the electrode i.

It should be noted that under certain conditions, the k2 model reducesto the original Shannon model provided by equation [1]. In particular,in the cases where only a single electrode is considered or whenmultiple electrodes where the fraction of the current through a givenelectrode is equal to the fraction of the total surface area that theelectrode provides (e.g., if 50% of the current is going through anelectrode that provides 50% of the total surface area, then the k2-valueis equivalent to k-value where A equals the total surface area and Qequals the total charge), the k2 model reduces to the original Shannonmodel.

Simplification of the k2 model to the original Shannon model in the caseof multiple electrodes can be described in the following proof. If thesurface area A is divided into n segments of arbitrary size—denoted asfractions of the total surface area f₂, . . . , f_(n)), such that f₁+f₂+. . . +f_(n)=1. If Q_(i)=f_(i)Q, and A_(i)=f_(i)A, it follows that:

$\frac{Q_{i}^{2}}{A_{i}} = {\frac{\left( {f_{i}Q} \right)^{2}}{f_{i}A} = {\frac{f_{i}^{2}Q^{2}}{f_{i}A} = {f_{i}{\frac{Q^{2}}{A}.}}}}$

By substitution,

${{k\; 2} = {{\log_{10}\left( {\sum\limits_{i = 1}^{n}{f_{i}\frac{Q^{2}}{A}}} \right)} = {\log_{10}\left( {\left( {\sum\limits_{i = 1}^{n}f_{i}} \right)\frac{Q^{2}}{A}} \right)}}},$

and given that

${\left( {\sum\limits_{i = 1}^{n}f_{i}} \right) = 1},{then}$${k\; 2} = {\log_{10}\left( \frac{Q^{2}}{A} \right)}$

It should be noted that for a given k-value threshold, the k2 model isconservative compared to the existing approach of evaluating the chargelimit on an electrode-by-electrode basis. That is, the k2 model cannotallow the original k-value on any one electrode (assuming anelectrode-by-electrode assessment approach) to breach the originalk-value threshold. That is not possible because in the k2 model, eachactive electrode (of a given polarity) counts against the totalpermissible k.

Having described the general concept of the k2 model, several examplesthat illustrate how the k2-value changes as current is distributed amongelectrodes, and highlight the scenarios in which the k2 model reduces tothe original Shannon model will now be described.

In the first example illustrated in FIGS. 5 a and 5 b, the split betweentwo electrodes (e1 and e2) of the same size is varied. As can be seen,the k2-value is highest when electrical current is concentrated on asingle electrode (i.e., 100%-0% or 0%-100% for electrodes e1 and e2,respectively), and lowest when electrical current is evenly distributedbetween electrodes e1 and e2 (50%-50% for electrodes e1 and e2,respectively). For electrical current splits that can be reduced toscenarios that fit the original Shannon model (100%-0%, 50%-50%, 0%-100%for electrodes e1 and e2, respectively), the original k-value andk2-value are the same, which exemplifies the conservative property ofthe k2 model.

In the second example illustrated in FIGS. 6 a and 6 b, the splitbetween two electrodes (e1 and e2) of different sizes (electrode e2 isfour times as large as electrode e1) is varied. As can be seen, thek2-value is highest when electrical current is concentrated on thesmallest electrode (100%-0% for electrodes e1 and e2, respectively), andlowest when electrical current is distributed between electrodes e1 ande2 in proportion to the surface areas of the electrodes e1 and e2(20%-80% for electrodes e1 and e2, respectively). For electrical currentsplits that can be reduced to scenarios that fit the original Shannonmodel (100%-0%, 20%-80%, 0%-100% for electrodes e1 and e2,respectively), the original k-value and k2-value are the same, whichexemplifies the conservative property of the k2 model.

In the third example illustrated in FIGS. 7 a and 7 b, the split betweenthree electrodes (e1, e2, and e3) of the same size is varied. As can beseen, the k2-value is highest when the electrical current is mostconcentrated (67%-33%-0% for electrodes e1, e2, and e3, respectively),and lowest when the electrical current is most distributed (33%-33%-33%for electrodes e1, e2, and e3, respectively). For electrical currentsplits that can be reduced to scenarios that fit the original Shannonmodel (33%-33%-33% for electrodes e1, e2, and e3, respectively), theoriginal k-value and k2-value are the same, which exemplifies theconservative property of the k2 model.

In the fourth example illustrated in FIGS. 8 a and 8 b, the splitbetween three electrodes (e1, e2, and e3) of different sizes (electrodee1 is twice as large as electrodes e2 and e3) is varied. As can be seen,the k2-value is highest when the electrical current is most concentratedon the smallest electrode (33%-67%-0% for electrodes e1, e2, and e3,respectively), and lowest when the electrical current is distributedbetween electrodes e1, e2, and e3 in proportion to the surface areas ofthe electrodes e1, e2, and e3. For electrical current splits that can bereduced to scenarios that fit the original Shannon model (50%-25%-25% or67%-33%-0% for electrodes e1, e2, and e3, respectively), the originalk-value and k2-value are the same, which exemplifies the conservativeproperty of the k2 model.

The foregoing examples suggest that the k2 model is a conservative, yetreasonable approach for managing charge injection with multipleelectrodes and multiple electrical sources. It should be noted thatequation [4] treats the charge at each active electrode equally.However, each of the active electrodes may be weighted to take intoaccount unequal contributions of the active electrodes on the k2-value.In particular, the k2-value of the active electrodes can be computed inaccordance with the following equation:

$\begin{matrix}{{{k\; 2} = {\log_{10}\left( {\sum\limits_{i = 1}^{n}{W_{i}\frac{Q_{i}^{2}}{A_{i}}}} \right)}},} & \lbrack 5\rbrack\end{matrix}$

where k2 is the tissue charge injection safety value, i is an electrodedesignator, n is the number of electrodes, Q_(i) is the charge injectedby the electrode i, A_(i) is the surface area of the electrode i, and Wiis a weighting for the electrode i. The weighting values W_(i) may behard-coded into the system or may be programmable by the user.

In one embodiment, the weighting values W_(i) for the respectiveelectrodes are determined based on the adjacency or proximity ofelectrodes to each other. In particular, equation [4] does not take therelative spatial location of multiple active electrodes into account,and could be excessively conservative when the active electrodes are farapart, and most applicable when the active electrodes are tightlyjuxtaposed. However, equation [5] can be used take the relative spatiallocation of the multiple active electrodes into account. For example,the weighting value W_(i) for a particular electrode may be an adjacencyweighting that may be relatively high if it is relatively close to areference electrode or relatively low (or zero) if it is relatively faraway from the reference electrode.

In one embodiment, the adjacent weighting value W_(i) may be binary(i.e., only two values are available), such that an active electrodethat is relatively far away from the reference electrode may be equal to0, and an active electrode that is relatively close to the referenceelectrode may be equal to 1. Thus, the active electrodes havingweighting values W_(i) of 0 do not affect the k2-value computed for theactive electrodes having weighting values W_(i) of 1. In anotherembodiment, the weighting value W_(i) may be graduated from 0 to 1 inincrements of, e.g., 0.1, in accordance with the proximity of therespective electrode from a reference electrode. Active electrodes thatare deemed to be relatively far away from the reference electrode may beassigned a weighting of 0, whereas the remaining electrodes may beassigned a non-zero weighting. For example, as illustrated in FIG. 9 a,electrodes e1-e5 are assigned non-zero weighting values W_(i) (withelectrode e3 being the reference electrode, and therefore, assigned aweighting of 1), whereas electrodes e6-e8 are assigned zero weightingvalues W_(i) due to their relatively far proximity to referenceelectrode e3. Thus, electrodes e6-e8 do not affect the k2-value computedfor electrodes e1-e5.

The concept of adjacency weightings W_(i) may be extended toneurostimulation leads. For example, the electrodes carried by oneneurostimulation lead can be uniformly weighted based on the proximityof that neurostimulation lead to a reference neurostimulation lead. TheCP 18 may have a toggle switch that can be actuated to alternately deemtwo neurostimulation leads to be relatively close to each other, inwhich case, the weighting values W_(i) for all the active electrodeswill be 1, or deem the two neurostimulation leads to be relatively faraway from each other, in which case, the weighting values W_(i) for allthe electrodes carried by the neurostimulation lead of interest will be1, whereas the weighting values W_(i) for all the electrodes carried bythe other neurostimulation lead will be 0.

Notably, several k2-values may be computed for different combinations ofthe active electrodes. For example, in the case where the weightingvalues W_(i) are binary, any of the active electrodes that have beenassigned a weighting value W_(i) of 0, may be selected as a referenceelectrode for determining adjacencies for other ones of the activeelectrodes. For example, a first k-value (k2_(a)) may be computed forelectrodes e1-e5, as previously discussed with respect to FIG. 9 a, anda second k2-value (k2_(b)) can be computed for electrodes e6-e8, whichwere assigned a weighting value W_(i) of 0 in FIG. 9 a. As shown in FIG.9 b, electrodes e6-e8 are assigned non-zero weightings (with electrodee7 being the reference electrode, and therefore, assigning a weightingof 1), whereas electrodes e1-e5 are assigned zero weightings due totheir relatively far proximity to reference electrode e7. Thus, twok2-values are respectively computed for electrodes e1-e5 and electrodese6-e8. For cases where multiple k2-values are computed, a function(e.g., a maximum, a sum, an average, or a minimum) of these k2-valueswill be compared to the safety threshold value (e.g., a hardstop limitand/or a warning threshold), and a corrective action will be performedif the function of the k2-values breach the safety threshold value.

In the case where the weighting values W_(i) are graduated, the totalnumber of k2-values computed may be equal to the total number of activeelectrodes, with each k2-value being associated with a combination ofelectrodes having a different reference electrode. That is, one of theactive electrodes can be selected as a reference electrode, and theremaining electrodes can be assigned weighting values W_(i) inaccordance to their proximities to the reference electrode; then, adifferent active electrode can be selected as a reference electrode, andthe remaining electrodes can be assigned weighting values W_(i) inaccordance to their proximities to the new reference electrodes; and soon.

Although the weighting values W_(i) have been described with respect toelectrode proximity, it should be noted that the weighting values W_(i)can be applied to other variable aspects of the electrodes or nature ofelectrical current delivered to the electrodes. For example, activeelectrodes that deliver cathodic electrical current may be weighteddifferently from active electrodes that deliver anodic electricalcurrent. In one embodiment, when computing a k2-value, active cathodicelectrodes may be assigned a weighting value W_(i) of 1.0, whereasactive anodic electrodes may be assigned a weighting value W_(i) of 0.4.Alternatively, active anodic electrodes may not be considered at allwhen computing the k2-value, in which case, they may be assigned aweighting value W, of 0.

In an optional embodiment, a computed k2-value or a safety thresholdvalue may be scaled up or down to create a final k2-value or finalsafety threshold value prior to comparison. In one embodiment, thesafety threshold value may take the form of a discrete function of thefrequency of the electrical current. For example, the safety thresholdvalue may be equal to 5 for frequencies in the range of 0 Hz to 100 Hz,and equal to 3 for frequencies above 100 Hz. In another embodiment, thesafety threshold value may be a continuous function of the frequency ofthe electrode electrical. For example, the safety threshold value may becomputed in accordance with either of the following equations: k2=m*F+b,or k2=a*F²+b*F+c, where a, b, c, and m are constants, and F is thefrequency of the electrical current.

In other embodiments, a plurality of different safety threshold valuesmay be stored in memory, one of which can be selected based on acharacteristic shared by the active electrodes for which the k2-valuewill be computed. For example, the stored safety threshold values may berespectively associated with different frequencies, in which case, thesafety threshold value associated with the frequency of the electricalcurrent is delivered to the active electrodes can be selected forcomparison to the computed k2-value. Or the stored safety thresholdvalues may be respectively associated with different polarities, inwhich case, the safety threshold value associated with the polarity ofthe electrical current delivered to the active electrodes can beselected for comparison to the computed k2-value.

Although the function of computing the k2-value and performing thecorrective actions has been described as being performed by the CP 18and/or IPG 14, it should be appreciated that the RC 16 may compute thek2-value and/or perform the corrective action. Although particularembodiments of the present inventions have been shown and described, itwill be understood that it is not intended to limit the presentinventions to the preferred embodiments, and it will be obvious to thoseskilled in the art that various changes and modifications may be madewithout departing from the spirit and scope of the present inventions.Thus, the present inventions are intended to cover alternatives,modifications, and equivalents, which may be included within the spiritand scope of the present inventions as defined by the claims.

What is claimed is:
 1. A neurostimulation system for use with aplurality of electrodes implanted within a tissue region, comprising: aneurostimulator configured for delivering electrical stimulation energyto the plurality of electrodes in accordance with a set of stimulationparameters, thereby injecting a charge into the tissue region; a controldevice configured for receiving user input to modify the set ofstimulation parameters; and controller/processor circuitry configuredfor, in response to the user input: computing a charge injection metricvalue as a function of a physical electrode parameter and an electricalsource parameter for a first set of the electrodes, wherein theelectrode set comprises at least two electrodes; comparing the computedcharge injection metric value to a safety threshold value; andperforming a corrective action based on the comparison.
 2. Theneurostimulation system of claim 1, wherein performing the correctiveaction comprises preventing the neurostimulation device from deliveringthe electrical stimulation energy to the plurality of electrodes.
 3. Theneurostimulation system of claim 1, wherein performing the correctiveaction comprises delivering the electrical stimulation energy to theelectrode set in accordance with a different set of stimulationparameters.
 4. The neurostimulation system of claim 1, whereinperforming the corrective action comprises directing the control deviceto convey a warning signal to the user.
 5. The neurostimulation systemof claim 1, wherein the controller/processor circuitry is configuredfor: directing the neurostimulator to deliver the electrical stimulationenergy to the plurality of electrodes in accordance with the modifiedstimulation parameter set if the computed charge injection metric valuedoes not breach the threshold charge injection metric value; andperforming the corrective action if the computed charge injection metricvalue breaches the threshold charge injection metric value.
 6. Theneurostimulation system of claim 1, wherein the physical electrodeparameter is at least one of an electrode surface area, an electrodesurface shape, and an electrode material.
 7. The neurostimulation systemof claim 1, wherein the electrical source parameter is at least one of acurrent, a voltage, a charge, charge density, and an impedance.
 8. Theneurostimulation system of claim 1, wherein the physical electrodeparameter is an electrode surface area, and the electrical sourceparameter is a charge.
 9. The neurostimulation system of claim 8,wherein the tissue charge injection safety value is computed inaccordance with the equation${{k\; 2} = {\log_{10}\left( {\sum\limits_{i = 1}^{n}\frac{Q_{i}^{2}}{A_{i}}} \right)}},$where k2 is the tissue charge injection safety value, i is an electrodedesignator, n is the number of electrodes, Q_(i) is the charge injectedby the electrode i, and A_(i) is the surface area of the electrode i.10. The neurostimulation system of claim 8, wherein the tissue chargeinjection safety value is computed in accordance with the equation${{k\; 2} = {\log_{10}\left( {\sum\limits_{i = 1}^{n}{W_{i}\frac{Q_{i}^{2}}{A_{i}}}} \right)}},$where k2 is the tissue charge injection safety value, i is an electrodedesignator, n is the number of electrodes, Q_(i) is the charge injectedby the electrode i, A_(i) is the surface area of the electrode i, and Wiis a weighting value for the electrode i.
 11. The neurostimulationsystem of claim 10, wherein the weighting value W_(i) is a binary value.12. The neurostimulation system of claim 10, wherein the weighting valueW_(i) is a graduated value.
 13. The neurostimulation system of claim 10,wherein the controller/processor circuitry is configured for determiningthe weighting value W_(i) for each electrode in the electrode set basedon an adjacency of the respective electrode relative to a referenceelectrode in the electrode set.
 14. The neurostimulation system of claim10, wherein the controller/processor circuitry is configured fordetermining the weighting value W_(i) for each electrode in theelectrode set based on a polarity of the respective electrode.
 15. Theneurostimulation system of claim 8, wherein the ratios between theinjected charge and the surface area for at least two of the electrodesare different.
 16. The neurostimulation system of claim 1, furthercomprising memory storing a plurality of different safety thresholdvalues, and the controller/processor circuitry is configured forselecting the safety threshold value from the different safety thresholdvalues based on a characteristic shared by the electrode set.
 17. Theneurostimulation system of claim 16, wherein the characteristic is oneof the same frequency and the same polarity.
 18. The neurostimulationsystem of claim 1, wherein the controller/processor circuitry isconfigured for, in response to the user input: computing at least oneother charge injection metric value as a function of a physicalelectrode parameter and an electrical source parameter for each of atleast one other set of the electrodes, wherein the electrode set andeach of the at least one other electrode set are different from eachother, and each of the at least other electrode set comprises at leasttwo electrodes; comparing a function of the computed charge injectionmetric value and the at least one other computed charge injection metricvalue to the safety threshold value; and performing the correctiveaction based on the computed function.
 19. The neurostimulation systemof claim 18, wherein the function is one of a maximum, a sum, anaverage, and a minimum of the charge injection metric value and the atleast one other charge injection metric value.
 20. The neurostimulationsystem of claim 1, wherein the neurostimulator is implantable.
 21. Theneurostimulation system of claim 1, wherein the control device comprisesthe controller/processor circuitry.
 22. The neurostimulation system ofclaim 1, wherein the control device is an external control device.